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Wellbutrin XL

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Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...

Wellbutrin XL

Wellbutrin XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Wellbutrin XL (bupropion hydrochloride extended-release) is used to treat major depressive disorder and seasonal affective disorder. At least one brand of bupropion (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects. It is an antidepressant. This medication is available in generic form. Common side effects include dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, joint aches, dizziness, or blurred vision.

The initial dose of Wellbutrin XL is 150 mg/day as a single dose. The target dose is 300-mg/day. Wellbutrin XL may interact with cancer medicines, heart rhythm medications, heart or blood pressure medications, other antidepressants, medicine to treat psychiatric disorders, antihistamines, asthma medications or bronchodilators, birth control pills or hormone replacement estrogens, bladder or urinary medications, antibiotics, diet pills, stimulants, ADHD medication, insulin or oral diabetes medications, medication for nausea/vomiting/motion sickness, medications to treat/prevent malaria, medicines to treat Parkinson's disease/restless leg syndrome/pituitary gland tumor, medicines used to prevent organ transplant rejection, narcotics, sedatives, steroids, theophylline, or ulcer or irritable bowel medications. Tell your doctor all medications you use. Wellbutrin XL should be used only when prescribed during pregnancy. Infrequently, newborns whose mothers have used certain antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Report symptoms to the doctor. Do not stop taking this medication unless your doctor directs you to do so. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Wellbutrin XL (bupropion hydrochloride extended-release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Wellbutrin XL in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • seizure (convulsions);
  • fast heartbeats;
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • confusion, trouble concentrating, hallucinations, unusual thoughts or behavior; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • dry mouth, nausea, stomach pain;
  • headache, dizziness, ringing in your ears;
  • loss of interest in sex;
  • sore throat, muscle pain;
  • mild itching or skin rash, increased sweating, increased urination; or
  • changes in appetite, weight loss or gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Wellbutrin XL (Bupropion Hydrochloride Extended-Release) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Wellbutrin XL Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Dry mouth, sore throat, dizziness, nausea, vomiting, ringing in the ears, headache, decreased appetite, weight loss, constipation, trouble sleeping, increased sweating, or shaking (tremor) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood changes (such as anxiety, agitation, confusion, unusual behavior/thinking, memory loss), unusual weight loss or gain.

Stop taking bupropion and get medical help right away if you have any very serious side effects, including: seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), painful sores in the mouth/around the eyes, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Wellbutrin XL (Bupropion Hydrochloride Extended-Release)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Wellbutrin XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

(See also WARNINGS and PRECAUTIONS.)

Major Depressive Disorder

WELLBUTRIN XL has been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion (see CLINICAL PHARMACOLOGY). The information included under this subsection is based primarily on data from controlled clinical trials with WELLBUTRIN SR, the sustained-release formulation of bupropion.

Adverse Events Leading to Discontinuation of Treatment With WELLBUTRIN or WELLBUTRIN SR

In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of the sustained-release formulation of bupropion and 4% of patients treated with placebo discontinued treatment due to adverse events. The specific adverse events in these trials that led to discontinuation in at least 1% of patients treated with either 300 mg/day or 400 mg/day of WELLBUTRIN SR, the sustained-release formulation of bupropion, and at a rate at least twice the placebo rate are listed in Table 6.

Table 6: Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials for Major Depressive Disorder

Adverse Event Term WELLBUTRIN SR 300 mg/day
(n = 376)
WELLBUTRIN SR 400 mg/day
(n = 114)
Placebo
(n = 385)
Rash 2.4% 0.9% 0.0%
Nausea 0.8% 1.8% 0.3%
Agitation 0.3% 1.8% 0.3%
Migraine 0.0% 1.8% 0.3%

In clinical trials with the immediate-release formulation of bupropion, 10% of patients and volunteers discontinued due to an adverse event. Events resulting in discontinuation, in addition to those listed above for the sustained-release formulation of bupropion, include vomiting, seizures, and sleep disturbances.

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With WELLBUTRIN or WELLBUTRIN SR

Table 7 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of bupropion and with placebo in controlled trials. Events that occurred in either the 300- or 400-mg/day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a COSTART-based Dictionary.

Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the events. A better perspective on the serious adverse events associated with the use of bupropion is provided in the WARNINGS AND PRECAUTIONS sections.

Table 7: Treatment-Emergent Adverse Events in Placebo-Controlled Trials* for Major Depressive Disorder

Body System/ Adverse Event WELLBUTRIN SR 300 mg/day
(n = 376)
WELLBUTRIN SR 400 mg/day
(n = 114)
Placebo
(n=385)
Body (General)
  Headache 26% 25% 23%
  Infection 8% 9% 6%
  Abdominal pain 3% 9% 2%
  Asthenia 2% 4% 2%
  Chest pain 3% 4% 1%
  Pain 2% 3% 2%
  Fever 1% 2%
Cardiovascular
  Palpitation 2% 6% 2%
  Flushing 1% 4%
  Migraine 1% 4% 1%
  Hot flashes 1% 3% 1%
Digestive
  Dry mouth 17% 24% 7%
  Nausea 13% 18% 8%
  Constipation 10% 5% 7%
  Diarrhea 5% 7% 6%
  Anorexia 5% 3% 2%
  Vomiting 4% 2% 2%
  Dysphagia 0% 2% 0%
Musculoskeletal
  Myalgia 2% 6% 3%
  Arthralgia 1% 4% 1%
  Arthritis 0% 2% 0%
  Twitch 1% 2%
Nervous system
  Insomnia 11% 16% 6%
  Dizziness 7% 11% 5%
  Agitation 3% 9% 2%
  Anxiety 5% 6% 3%
  Tremor 6% 3% 1%
  Nervousness 5% 3% 3%
  Somnolence 2% 3% 2%
  Irritability 3% 2% 2%
  Memory decreased  3% 1%
  Paresthesia 1% 2% 1%
  Central nervous system stimulation 2% 1% 1%
Respiratory
  Pharyngitis 3% 11% 2%
  Sinusitis 3% 1% 2%
  Increased cough 1% 2% 1%
Skin
  Sweating 6% 5% 2%
  Rash 5% 4% 1%
  Pruritus 2% 4% 2%
  Urticaria 2% 1% 0%
  Special senses
  Tinnitus 6% 6% 2%
  Taste perversion 2% 4%
  Blurred vision or diplopia 3% 2% 2%
Urogenital
  Urinary frequency 2% 5% 2%
  Urinary urgency 2% 0%
  Vaginal hemorrhagef 0% 2%
  Urinary tract infection 1% 0%
*Adverse events that occurred in at least 1% of patients treated with either 300 or 400 mg/day of the sustained-release formulation of bupropion, but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder.
†Incidence based on the number of female patients.
- Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.

Additional events to those listed in Table 7 that occurred at an incidence of at least 1% in controlled clinical trials of the immediate-release formulation of bupropion (300 to 600 mg/day) and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase (4% vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%).

Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials

Adverse events from Table 7 occurring in at least 5% of patients treated with the sustained-release formulation of bupropion and at a rate at least twice the placebo rate are listed below for the 300- and 400-mg/day dose groups.

300 mg/day of WELLBUTRIN SR

Anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of WELLBUTRIN SR

Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency.

Seasonal Affective Disorder

Adverse Events Leading to Discontinuation of Treatment With WELLBUTRIN XL

In placebo-controlled clinical trials, 9% of patients treated with WELLBUTRIN XL and 5% of patients treated with placebo discontinued treatment due to adverse events. The adverse events in these trials that led to discontinuation in at least 1% of patients treated with WELLBUTRIN XL and at a rate numerically greater than the placebo rate are insomnia (2% vs < 1%) and headache (1% vs < 1%).

Adverse Events Occurring at an Incidence of 2% or More Among Patients Treated With WELLBUTRIN XL

Table 8 enumerates treatment-emergent adverse events that occurred among patients treated with WELLBUTRIN XL for up to approximately 6 months in 3 placebo-controlled trials. Events that occurred at an incidence of 2% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a MedDRA-based Dictionary.

Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions; e.g., different patient populations, different treatment durations.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the events. A better perspective on the serious adverse events associated with the use of bupropion is provided in the WARNINGS AND PRECAUTIONS sections.

Table 8: Treatment-Emergent Adverse Events* in Placebo-Controlled Trials of Seasonal Affective Disorder

System Organ Class/ Preferred Term WELLBUTRIN XL
(n = 537)
Placebo
(n = 511)
Gastrointestinal Disorder
  Dry Mouth 26% 15%
  Nausea 13% 8%
  Constipation 9% 2%
  Flatulence 6% 3%
  Abdominal pain 2% < 1%
Nervous System Disorders
  Headache 34% 26%
  Dizziness 6% 5%
  Tremor 3% < 1%
Infections and Infestations
  Nasopharyngitis 13% 12%
  Upper respiratory tract infection 9% 8%
  Sinusitis 5% 4%
Psychiatric Disorders
  Insomnia 20% 13%
  Anxiety 7% 5%
  Abnormal dreams 3% 2%
  Agitation 2% < 1%
Musculoskeletal and Connective Tissue Disorders
  Myalgia 3% 2%
  Pain in extremity 3% 2%
Respiratory, Thoracic and Mediastinal Disorders
  Cough 4% 3%
General Disorders and Administration Site Conditions
  Feeling jittery 3% 2%
Skin and Subcutaneous Tissue Disorders
  Rash 3% 2%
Metabolism and Nutrition Disorders
  Decreased appetite 4% 1%
Reproductive System and Breast Disorders
  Dysmenorrhea 2% < 1%
Ear and Labyrinth Disorders
  Tinnitus 3% < 1%
Vascular Disorders
  Hypertension 2% 0%
*Adverse events that occurred in at least 2% of patients treated with WELLBUTRIN XL, but equally or more frequently in the placebo group, were: abdominal pain upper, arthralgia, back pain, diarrhea, dyspepsia, fatigue, gastroenteritis viral, hyperhidrosis, influenza, irritability, migraine, nasal congestion, neck pain, palpitations, pharyngolaryngeal pain, sinus congestion.

Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials

Adverse events from Table 8 that occurred in at least 5% of patients treated with WELLBUTRIN XL and at a rate at least twice the placebo rate were constipation and flatulence.

Adverse Events During Taper or Following Discontinuation of WELLBUTRIN XL

Adverse events with onset during the 2 weeks following downtitration of WELLBUTRIN XL from 300 mg/day to 150 mg/day were reported by 14% of patients compared to 18% of patients who continued on placebo.

Adverse events with onset during the 2 weeks following discontinuation of WELLBUTRIN XL were reported by 9% of patients compared with 12% of patients following discontinuation of placebo.

Other Events Observed During The Clinical Development And Postmarketing Experience Of Bupropion

In addition to the adverse events noted above, the following events have been reported in clinical trials and postmarketing experience with the sustained-release formulation of bupropion in depressed patients and in nondepressed smokers, as well as in clinical trials and postmarketing clinical experience with the immediate-release formulation of bupropion.

Adverse events for which frequencies are provided below occurred in clinical trials with the sustained-release formulation of bupropion. The frequencies represent the proportion of patients who experienced a treatment-emergent adverse event on at least one occasion in placebo-controlled studies for depression (n = 987) or smoking cessation (n = 1,013), or patients who experienced an adverse event requiring discontinuation of treatment in an open-label surveillance study with the sustained-release formulation of bupropion (n = 3,100). All treatment-emergent adverse events are included except those listed in Tables 2 through 8, those events listed in other safety-related sections, those adverse events subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events not reasonably associated with the use of the drug, and those events that were not serious and occurred in fewer than 2 patients. Events of major clinical importance are described in the WARNINGS AND PRECAUTIONS sections of the labeling.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, while rare events are those occurring in less than 1/1,000 patients.

Adverse events for which frequencies are not provided occurred in clinical trials or postmarketing experience with bupropion. Only those adverse events not previously listed for sustained-release bupropion are included. The extent to which these events may be associated with WELLBUTRIN XL is unknown.

Body (General): Infrequent were chills, facial edema, musculoskeletal chest pain, and photosensitivity. Rare was malaise. Also observed were arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness (see PRECAUTIONS).

Cardiovascular: Infrequent were postural hypotension, stroke, tachycardia, and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe, see PRECAUTIONS), myocardial infarction, phlebitis, and pulmonary embolism.

Digestive: Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis, and thirst. Rare was edema of tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis, and stomach ulcer.

Endocrine: Also observed were hyperglycemia, hypoglycemia, and syndrome of inappropriate antidiuretic hormone.

Hemic and Lymphatic: Infrequent was ecchymosis. Also observed were anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia, and thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was coadministered with warfarin.

Metabolic and Nutritional: Infrequent were edema and peripheral edema. Also observed was glycosuria.

Musculoskeletal: Infrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness.

Nervous System: Infrequent were abnormal coordination, decreased libido, depersonalization, dysphoria, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, suicidal ideation, and vertigo. Rare were amnesia, ataxia, derealization, and hypomania. Also observed were abnormal electroencephalogram (EEG), aggression, akinesia, aphasia, coma, completed suicide, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt, and unmasking tardive dyskinesia.

Respiratory: Rare was bronchospasm. Also observed was pneumonia.

Skin: Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis, and hirsutism.

Special Senses: Infrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure, and mydriasis.

Urogenital: Infrequent were impotence, polyuria, and prostate disorder. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention, and vaginitis.

Drug Abuse And Dependence

Controlled Substance Class

Bupropion is not a controlled substance.

Humans

Controlled clinical studies of bupropion (immediate-release formulation) conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed patients showed some increase in motor activity and agitation/excitement.

In a population of individuals experienced with drugs of abuse, a single dose of 400 mg of bupropion produced mild amphetamine-like activity as compared to placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI), and a score intermediate between placebo and amphetamine on the Liking Scale of the ARCI. These scales measure general feelings of euphoria and drug desirability.

Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose studies does suggest that the recommended daily dosage of bupropion when administered in divided doses is not likely to be especially reinforcing to amphetamine or stimulant abusers. However, higher doses that could not be tested because of the risk of seizure might be modestly attractive to those who abuse stimulant drugs.

Animals

Studies in rodents and primates have shown that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavioral response, and increase rates of responding in several schedule-controlled behavior paradigms. In primate models to assess the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. In rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.

Read the entire FDA prescribing information for Wellbutrin XL (Bupropion Hydrochloride Extended-Release) »

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Wellbutrin XL - User Reviews

Wellbutrin XL User Reviews

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